KETOTIFEN FUMARATE solution

Ketotifen Fumarate by

Drug Labeling and Warnings

Ketotifen Fumarate by is a Otc medication manufactured, distributed, or labeled by Advanced Vision Research (Subsidiary of Akorn, Inc.), Akorn, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Ketotifen (0.025%)

(equivalent to Ketotifen Fumarate 0.035%)

Purpose

Antihistamine

Uses

Temporary relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

Warnings

Do not use

• if solution changes color or becomes cloudy
• if you are sensitive to any ingredient in this product
• to treat contact lens related irritation

When using this product

• do not touch tip of container to any surfaces to avoid contamination
• remove contact lenses before use
• wait at least 10 minutes before reinserting contact lenses after use
• replace cap after each use

Stop use and ask a doctor if you experience any of the following:

• eye pain
• changes in vision
• redness of the eye
• itching worsens or lasts for more than 72 hours

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day.
• Children under 3 years of age: Consult a doctor.

Other information

• Only for use in the eye.
• Store at 20°C to 25°C (68° to 77° F) [see USP Controlled Room Temperature].

Inactive ingredients

Benzalkonium Chloride 0.01%; Glycerin and Purified Water. May contain Hydrochloric Acid and/or Sodium Hydroxide (to adjust pH).

Questions?

call toll-free 1-800-579-8327, weekdays, 7:00 AM-5:30 PM EST

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

Thera Tears logo NDC: 58790-008-05
Ketotifen Fumarate
Ophthalmic Solution
ANTIHISTAMINE EYE DROPS
Sterile                EYE ITCH
5mL (0.17 FL OZ)      RELIEF

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

Thera Tears logo
Ketotifen Fumarate
Ophthalmic Solution
Antihistamine Eye Drops STERILE
EYE ITCH
RELIEF
Up to
12
Hours

• Works in Minutes
• Original Prescription
  Strength
• For Ages 3 Years and Older
• 30 Day Supply

                      ADVANCED
                      VISION RESEARCH logo
0.17 FL OZ (5 mL)     AN AKORN COMPANY

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

Thera Tears logo NDC: 58790-008-10

Ketotifen Fumarate

Ophthalmic Solution

ANTIHISTAMINE EYE DROPS

Sterile ALLERGY

EYE ITCH

0.34 FL OZ (10 mL) RELIEF

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

100% More Free*

*10 ml for the

price of

5 ml

Thera Tears logo

Ketotifen Fumarate

Ophthalmic Solution

Antihistamine Eye Drops STERILE

ALLERGY

EYE ITCH

RELIEF

Up to

12

Hours

• Works in Minutes
• Original Prescription
  Strength
• For Ages 3 Years and Older
• 60 Day Supply

ADVANCED

VISION RESEARCH logo

0.34 FL OZ (10 mL) AN AKORN COMPANY

INGREDIENTS AND APPEARANCE

KETOTIFEN FUMARATE 
ketotifen fumarate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58790-008
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Ketotifen Fumarate (UNII: HBD503WORO) (Ketotifen - UNII:X49220T18G)	Ketotifen Fumarate	0.35 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Benzalkonium Chloride (UNII: F5UM2KM3W7)
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)
Hydrochloric Acid (UNII: QTT17582CB)
Sodium Hydroxide (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58790-008-05	1 in 1 CARTON
1		5 mL in 1 BOTTLE, DROPPER
2	NDC: 58790-008-10	1 in 1 CARTON
2		10 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077958	03/15/2012

Labeler - Advanced Vision Research (Subsidiary of Akorn, Inc.) (969124536)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc		603980319	MANUFACTURE(58790-008) , ANALYSIS(58790-008) , STERILIZE(58790-008) , PACK(58790-008) , LABEL(58790-008)